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Given the sample size is large enough (and it surely is) they would have no effect on the results of the study, at least as regards a statistically significant difference in relapse rate.

The people that I have communicated to about this topic and who know a heck of a lot more about clinical trials than I ever will, appear to have a very different opinion on the use of steroids. I guess we'll have to agree to have different thoughts on this as I have a lot of confidence in their judgment.

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The FDA would have most certainly looked at steriod use in the event of an exacerbation. The FDA have clearly indicated that Tysabri offers a substantial reduction in relapse rate. Period. This is a public fact, NOT unamed sources or hearsay. I strongly urge readers to consider FACTS in preference to hearsay and unamed sources.

I might also note that Tysabri substantially reduced the need for steroids in the Crohn's trials.

Different diseases, to be sure. But I note that since Tysabri substantially reduced the number of relapses in the MS trials, the need for steriods was probably also substantially reduced relative to placebo. This is simple common sense.

2. Doctors involved in the trial

I cannot find any posts from MS Forums saying that patients saying that their Doctors involved in the trial are sceptical about Tysabri. I certainly would appreciate ANY links to such posts, so that these comments could be verified or at least reviewed.

Indeed, I believe the truth suggests the opposite, with many or all of the participants in the 2-yr trials converting to Tysabri for the extension safety/efficacy trials. This is clearly suggestive that the trial Docs are seeing substantial benefits of Tysabri use. This is heresay, I might add.

It is NOT hearsay to point out that the ThisisMS Tysabri poll shows some 53+% of poll participants wishing to immediately try Tysabri, with about 29% choosing to await further information/data.

Finally, on a general point, IMHO it is entirely acceptable to state opinions on the board. But I think we must recognize them as such, and not mistake opinions for facts. For example, I have a number of contacts who are very postive on Tysabri and indeed the FDA approval, label, and substantial published research supports their view. This leads to my positive bias on Tysabri. However, I don't think it appropriate to reference my contacts in support of my arguments. Others think and do differently, and that is quite all right by me, but we should recognise it for what it is.

I cannot find any posts from MS Forums saying that patients saying that their Doctors involved in the trial are sceptical about Tysabri. I certainly would appreciate ANY links to such posts, so that these comments could be verified or at least reviewed.

Perhaps you weren't looking in the right areas. The following quotes were taken from the MS Foundation (www.msfacts.org)website in August of this year. This is one of many sites that I visit and is a very good, overall informative site for MS readers.

Post 1.

"I have talked to my neuro about Antegren, as he is involved in some of the studies. He isn't that thrilled with it, because some patients stop breathing after taking it. It has to be administered in a hospital and not a dr's office due to the breathing problems that may result. It's not a huge percentage of people who stop breathing, but my dr said the % is high enough that he wouldn't recommend it to his patients.

He also told me that they didn't know if it would work if administered w/out a CRAB, and so at least for now, they are saying you have to be on one in addition to the antegren for it to show any promise.

I hope they iron out the bugs and this proves to be a promising treatment. Just thought I'd share what my MS specialist had to say about it. Terri "

Post 2.

"Hi everyone - here is an article I came across on Antegren. (I can't remember if I am supposed to just paste the link or the whole thing, so here's the whole thing.) In case you can't or don't want to read it, here's the gist: Basically, Biogen is waiting to release it's clinical data on Antegren until it finds out if the FDA is going to approve it. Sounds a little fishy to me, and apparently also to the author of this article.

Remember how I told you guys that Dr. Low Talker told me that patients were stopping breathing with Antegren and that it couldn't be given in a dr's office, only in a hospital because of the breathing issue? Neither of these is mentioned a lot -- wonder if that's why they are waiting to disclose clinical data?? Or, maybe they are just worried about Avonex marketshare? Guess we'll learn what's up soon enough. Teri"

Now for those who think that I make up my comments please note the doc's name and and contact him if you feel it necessary. I believe he is located in Ohio. This is one of many comments that I have come accross on various sites and simply indicates that there are different views held by some docs about Tysabri.

Again, I don't make this stuff up...only repeat what I find on the net.

If you look at the link supplied by another reader in the another post in this thread re: the concern about the FDA in drug approvals, you will see that all the hype about drugs doesn't guarantee for one second that a drug may be good and safe. We simply don't know enough about Tysabri as yet and it will be some time, after peer reviewing and general population use, that a more scientific opinion can be given.

Finally, on a general point, IMHO it is entirely acceptable to state opinions on the board. But I think we must recognize them as such, and not mistake opinions for facts. For example, I have a number of contacts who are very postive on Tysabri and indeed the FDA approval, label, and substantial published research supports their view. This leads to my positive bias on Tysabri. However, I don't think it appropriate to reference my contacts in support of my arguments. Others think and do differently, and that is quite all right by me, but we should recognise it for what it is.

If a number of people want to be very enthusiastic about Tysabri then that is fine. But don't expect that everyone, including several in the field of medicine, to share that enthusiasm. Everybody has their reasons for their opinions. And because the FDA has conditionally approved Tysabri, it doesn't mean the drug is going to be all that Biogen says it will be. Just read the article from the link that I mentioned and you will see why.

I thought there might be something more substantive than these posts to support comments about the medical community's concern with Tysabri. Clearly I was looking in the right areas, as I had seen these two and did NOT think it significant. That, of course, is a matter of opinion.

The first post is clearly wrong with regard to several items - (1) monotherapy appears to have a much greater effect on relapse rate, (2) the infusions can indeed be done in a Doctor's office, and (3) we know adverse events were very rare for the 2000+ people involved in the trial - 2% compared to 1% on placebo, and that all of these cases were apparently successfully handled.

With regard to the 2nd, this seems to refer to the The Street.com's comments on Biogen/Idec and Elan's 17 Aug 04 press release saying that data would be released upon approval. The FDA required delayed data release - and if necessary I can provide numerous links to prove this - as it was NOT in the Company's interests to embargoe data from the public and insurers/payors.

Then the post refers to the adverse reactions which appear to be mentioned in the first post. Again, the data show that these are very low level and substantially less than other drugs.

I guess the point is, whould you take a 1% chance of an adverse reaction, or a chance of a life-altering relapse? This, obviously, is something that only patients and their doctors can decide upon.

I guess I cannot see the 'negatives' in these posts, and indeed subsequent events has cast doubt on the accuracy of both of these posts. But I certainly agree with you that Doctors certainly hold different opinions about Tysabri, starting obviously with the MDs working at Serono, Pfizer, Teva, Schering, BIIB and ELN.

Is there more? I'm open, but I just can't get past the facts of approval and the 66% reduction in relapses.

With regard to the article about drug safety, this is broadly applicable to ALL drugs, not just Tysabri. I beg to differ with you on whether we know enough about Tysabri. Obviously we know the FDA approved it, and that it will be used by a substantial number of MS sufferers. Is more information/data needed - yes, as ALWAYS with any drug. But is there enough to start using it? A matter of opinion, with no right or wrong. I hope we'll agree to disagree on that one, and leave it at that.

I don't think that all folks in the medical community will be enthusiastic about Tysabri. Many will, some won't. It is important to remember that the article was NOT specifically about Tysabri - indeed, I believe it pointed out that a few drugs (out of the hundreds that the FDA has approved) have had problems. I believe the percentage is quite low (<1%???) and that FACT should be recognised by readers.

The FDA does indeed usually get it right, a significant amount of the time, much to the benefit of all patients. Unfortunately, the errors tend to get the headlines, and people forget what a good job the FDA is doing. Sure, it only takes one to be a real tragedy, but what of the thousands that the FDA approvals and oversight have helped. Its always a tradeoff - risk/reward.

Will Tysabri be the drug that Biogen Idec and Elan say it will be? Time will tell, but a 66% reduction in relapses is a great way to start. Wait for the EDSS, and then further discussions will be that much more interesting!

I thought there might be something more substantive than these posts to support comments about the medical community's concern with Tysabri. Clearly I was looking in the right areas, as I had seen these two and did NOT think it significant. That, of course, is a matter of opinion.

Did not think it was significant that a doctor involved in the actual trial voiced his concern over Tysabri and would not recommend it to his patients...ah, OK..ah whatever!!!!

Rather than continually flog a dead horse in this thread, the fact remains that we have two different opinions on Tysabri...yours being full steam ahead regardless of the lack of any kind of long term data (long term being two years!) and mine being caution because of what I have heard and read from others much closer to the situation. I just don't have full trust in drug companies nor the FDA after what has happened recently. That article on the FDA drug approval process substantiates my lack of trust.

Maybe Tysabri, in the long run, will turn out every bit as good as Biogen is telling us. Maybe it will turn out to be terribly disappointing. We just don't know at this point and like you stated, time will tell. Perhaps you will be right, I may be right or the result will lie somewhere in the middle. I hope for the sake of MS patients everywhere Biogen comes through with this new drug....otherwise the fallout will be devastating to the world of MS medicine.

Which is it - do you want to be right? or do you want to voice concerns?

This is the fundamental problem I have with your posts: they are not reasonable words of caution, IMO, they are wild comparisons with Vioxx and desperate searches for something, anything, that would indicate Tysabri will be a disaster.

All the available data and comments from clinical investigators point to a new level of efficacy and lack of side effects. Using Occam's Razor, a logical person should accept the simpler solution, and that is that Tysabri is a best-in-class drug with lowest side effects.

Which is it - do you want to be right? or do you want to voice concerns?

You are misreading my intent here. The reference to "right" or not has to do with the views and opinions that have been expressed by the both of us and are very different, to say the least. We have taken the same information and viewed it from a different perspective.

This is the fundamental problem I have with your posts: they are not reasonable words of caution, IMO, they are wild comparisons with Vioxx and desperate searches for something, anything, that would indicate Tysabri will be a disaster.

Why do you say that comparing Tysabari and Vioxx are wild comparisons? Vioxx had clinical trials conducted, was approved glowingly by the FDA but the data, as we discovered later, wasn't fully being disclosed. The FDA's own employee blew the whistle and the FDA tried to muzzle him. I'm comparing the "process" of what happened not drug vs drug. Does this happen all the time...of course it doesn't!! But it has happened more than once which means it has the capability of happening again. I'm sorry that you feel my words aren't words of "reasonable caution". That is your opinion but it certainly isn't shared by everyone.

All the available data and comments from clinical investigators point to a new level of efficacy and lack of side effects. Using Occam's Razor, a logical person should accept the simpler solution, and that is that Tysabri is a best-in-class drug with lowest side effects.

So what do we say about the "clinical investigators" who worked on Vioxx? At some point they knew very well about the dangers of that drug and from what we have been told, it was many, many months before Merck finally pulled it from the shelf. The warnings were "simple" but the resulting action by Merck was anything but. I'm not saying that Tysabri will follow in the same footsteps but again, until we have all the data, the drug gets used for many months and is peer reviewed, we really won't know the full efficacy about the drug. Why is that so difficult to comprehend?

There it is, plain and simple.

Use that quote on the those who didn't do very well on Vioxx, Neurontin or Rezulin....I'm sure they would appreciate it!

Now you are being hysterical about Tysabri. This may be news to you, but clinical trials are run on every drug that is approved by the FDA. Claritin and Ibuprofen have been approved by the FDA. So, according to your reasoning, perhaps Tysabri has the same dangers as antihistamines?The FDA oversees salad dressings and Ketchup, too: maybe Tysabri is safe enough to have with your french fries... You are adamant about comparing Tysabri to total disasters, and that is OK, but other readers here need to see some perspective on those comparisons since you post so prolifically and always in the same vein.

Why do you say that comparing Tysabari and Vioxx are wild comparisons? Vioxx had clinical trials conducted, was approved glowingly by the FDA but the data, as we discovered later, wasn't fully being disclosed. The FDA's own employee blew the whistle and the FDA tried to muzzle him. I'm comparing the "process" of what happened not drug vs drug. Does this happen all the time...of course it doesn't!! But it has happened more than once which means it has the capability of happening again. I'm sorry that you feel my words aren't words of "reasonable caution". That is your opinion but it certainly isn't shared by everyone.

Lets take a look at this. The drug withdrawl rate of FDA approved drugs is what, 2%? I think it is likely less, but lets be liberal. So Vioxx is one of those 2%. Now, some are suggesting for unknown reasons that Tysabri will also be in that 2%. Why?

Seems to me that the more logical conclusion is:

THERE IS A 98% CHANCE THAT TYSABRI WILL NOT BE WITHDRAWN.

Why would ANYONE conclude/compare Tysabri and Vioxx? Perhaps because Vioxx is in the news and hence this is a common, logical error in decisionmaking: being unduly influenced by the most sensational or recent data.

We ALL should be aware of this bias, and NOT be mislead by comparisons between Vioxx and Tysabri. THERE IS NO DIRECT COMPARISON (other than FDA approval), AND SUGGESTIONS OTHERWISE ARE VERY LIKELY IN ERROR AND ARE INFLAMMATORY. IF THERE IS ANY BASIS FOR THE COMPARISON, PLEASE PROVIDE THE DATA/LINKS. OTHERWISE, WHY THE CONTINUED REFERENCE TO VIOXX?

And in reference to another post referring to ONE doctor involved in the clinical trials who was not enthusiastic about Tysabri, I note that there were 99 sites in AFFIRM and 123 sites in SENTINEL, or some 212 sites. Assuming that there was ONLY 1 doctor/site, that means 212 doctors. And we're citing ONE who has doubts (in August, I might add, before FDA approvals). That's 1 out of 212. Again, as with the Vioxx and Tysabri comparisons, this concern seems to be on the VERY small end of the percentages. Hmmm.

In sum, seems that the wise choice is to bet the percentages. That, of course, is up to each patient and their doctor.

Ted Phillips, a specialist in MS at Texas Neurology who led some of the Tysabri trials, says he plans to mostly use Tysabri alone as the new first-line weapon against MS. His reason? Even by itself, Tysabri is twice as effective as any of the existing drugs alone.

There are plenty more Doctors saying similar things, but I just happened to come across this today so thought I'd post it to bring some balance and comparison to the ONE Doctor quoted in Aug 04 saying he 'was not thrilled with it (Tysabri).'

I note the other Doctor mentioned in that previous post here, Dr. Low Talker, only mentioned side effects, NOT whether he was/was not impressed with Tysabri's efficacy. I honestly wonder what his view is on Tysabri.

Ok, I'm jumping in here, but please do not assume that I'm trying to throw stones or be inflammatory. I just felt the need to point out something.

Any company (or individual, for that matter) creates their own reputation of integrity and character. Previous posts in other threads regarding Antegren/Tysabri and independent research links that WERE provided in those posts, which showed how and/or where certain correlations or possible conclusions had been reached in some of our minds about Tysabri HAD been provided to the pro-Tysabri side of this debate. That evidence was completely ignored by the pro-Tysabri side, and instead personal attacks were parlayed instead. (That's over.)

BUT.......if there is request AGAIN now for specific links and evidence of how or where the anti- or to be more precise, the "questioning" of Tysabri perspective comes from, please refer back to those previous threads, which may at least explain some things. Of course, agreement with our correlations is not expected, but the claim that "links" or evidence of why or how we have questions has not been provided appears to not be able to sustain itself, as that evidence of how some perspectives were arrived at IS there.

As for my earlier mention herein regarding "integrity" and honesty of companies, and I totally understand if someone does not agree with my position on this, but in Biogen's OWN filings with the SEC indicating they have had RICO charges filed against them (that's racketeering, which is somewhat uncommon to be charged with...pretty serious stuff, there), and from some FDA letters that were sent to them asking them to retract misleading statements that Biogen had been spreading about earlier drugs, their reputation itself has been at the very least "tarnished" in some people's minds. And it wasn't tarnished by the public, it appears to have been tarnished within the industry itself somehow and/or by Biogen itself. Nobody else should be blamed for that information (which is available to the public eye right on Biogen's website) but the parties directly involved and/or Biogen itself. Every person and/or corporation holds personal responsibility for their own reputations.

So, even though I agree that this does not PROVE that Tysabri and its efficacy should be just thrown out the window, you have to admit that some of the above at least results in many people, including some physicians, to take the total picture into account (including perhaps some less than ideal data that has been provided or has NOT been provided in some people's minds) and therefore may result in those people at the very least expressing "caution" about Tysabri.

And I truly believe that is all Harry is trying to explain. That due to several things he has heard, read, and from purely his perspective, he simply is of the opinion that "caution"..........nothing more...........but "caution" MAY be indicated.

Lets just hope we get the totality of the data out sooner rather than later.

I must admit that I am disappointed that many companies (Pfizer, Biogen Idec, etc) have not (to my knowledge) elected to disclose ALL of their drug trial data in a public forum or website. Some companies certainly have (Lily, J&J? though I admit that I've not looked at any of these websites). They should be commended for their efforts. Those companies that are not disclosing all data just add to the fears of many. Hope that changes soon.

Perhaps one of the problems/concerns of the companies is, I'm sure, that statistics can/would be manipulated by competitors for marketing purposes. As Samuel Clemens said - there are 3 types of mendacity: lies, damn lies, and statistics. Sad, but true.

Yes, I agree with your sentiments. And due to that very practice that you mention (competitor spats, if you will), that is why for the most part (but not always, of course........usually only for the sake of conversation, though) that I put little stock into "media" press releases.

If you are equating "hysteria" to "caution" then you have been missing my entire point in all of this. I guess there isn't much more for me to say on this because the more I try and explain, the more you misinterpret.

You are adamant about comparing Tysabri to total disasters,

How many times do I have to explain to you, MS, I am comparing the "process" and NOT one drug versus another drug. I am taking a situation that happened with Vioxx and other drugs and stating that despite the clinical trials, despite all the favorable data and despite the good intentions of the FDA, those drugs ended up causing real harm to the users. I am then saying that I hope the same thing doesn't happen to Tysabri because we have very little data right now for independent parties to look at and view. Good grief, MS, the two year trials aren't totally finished as yet, the EDSS scores haven't been tabulated and the general population has JUST begun using Tysabri.

Please don't continue to place words into my mouth and make it seem like I'm some kind of radical nut running around trying to scare the hell out of people. If you want clarification on what I am trying to say, then please ask for the clarification. If you don't agree with what I have to say then fine, simply tell me you don't agree with it. I don't expect everyone to agree with what I write all the time and others have voiced such disagreement to me. But they don't try and characterize me and tell people what they think I mean.

I also think it's time to end this part of the thread. You and I don't agree on several items when it comes to Tysabri. Let's leave it at that for the sake of the readership here.

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